JP2022502162A - Artificial retouching tool manufacturing method and artificial retouching tool - Google Patents

Abstract

The present invention is a method of making an artificial prosthesis, particularly an orthotic device liner (2), wherein the artificial prosthesis is made from at least one fabrication material (12) using at least a partially additional fabrication method. The present invention relates to a method characterized in that the material to be produced is inserted into a support material in a fluid state and then cured.

Description

The present invention relates to a method for producing an artificial prosthesis, particularly an artificial orthotic device liner. The present invention further relates to artificial modifiers that are or can be made according to such methods.

Artificial prostheses are specifically interpreted in this case as orthotics and orthotic devices and their components. Orthodontic shoes, insoles and similar equipment are also considered artificial retouchers.

Artificial correctors have long been known in the art and are manufactured and sold in many different forms for different use cases. In doing so, a large number of different materials are used that take into account the different requirements summaries of each artificial corrector. That is, for example, an artificial device shaft is manufactured for a foot artificial device, and a cutting stump, for example, a thigh stump is inserted into the artificial device shaft. The prosthesis shaft is designed to be able to withstand a huge load in part, and to ensure the wearer of the prosthesis is assured of a solid feel as well as the highest possible comfort. Must have sufficient mechanical stability and strength. In addition, the prosthetic shaft should be as light as possible in net weight, which further enhances comfort. Today such prosthetic shafts are mostly made from carbon fiber composites with a light net weight and extremely high mechanical strength. As an interface between the prosthetic shaft and the cutting stump, a prosthetic liner made from a cushioning and elastic material, such as silicone or polyurethane, is often used. This prosthetic liner is worn over the cut stump, like a sock, before the cut stump is introduced into the prosthetic shaft along with the prosthetic liner.

Today, prosthetic shafts are generally tailored to the patient and molded from the cut stump in one of several well-known methods, whereas prosthetic liners are individual based on their elasticity. Since it is matched to the conditions of, it is generally manufactured with standard dimensions.

The prosthesis itself is placed at the stump and fixed to the stump. There are various systems for its fixation. The fixation system envisions so-called vacuum shaft technology, where the volumetric space between the stump and the inner wall of the prosthetic shaft is evacuated in the pressed state. A prosthetic liner may be placed on the stump for sealing and impact mitigation, the prosthetic liner generally having a closed distal end and a proximal insertion slot, surrounding the stump. do. Between the outside of the prosthesis liner and the inside of the prosthesis shaft, a volumetric space is formed by the introduction of a stump to which the prosthesis liner is applied, which is drawn into a vacuum, thereby causing the prosthesis. A crimp connection occurs between the shaft and the prosthetic liner. Since the prosthesis liner is in close contact with the prosthesis shaft via the adhesion force, the prosthesis shaft and the components fixed to the prosthesis shaft are fixed to the patient's stump. In order to sustainably secure the prosthesis shaft, it is necessary to seal the volumetric space between the prosthesis liner and the prosthesis shaft to the atmosphere. To that end, a so-called cap or cover is provided that is mounted on the proximal edge of the prosthesis shaft and adjacent to the outside of the prosthesis liner or stump so that the proximal edge of the prosthesis shaft and the prosthesis liner are provided. Alternatively, air cannot enter the gap between the stump and the stump. Instead of a cover or cap, a sealing lip may be placed or secured on the outside of the liner or inside the prosthetic shaft to seal the volumetric space.

Prosthetic shafts are generally made from shape-stability materials such that additional prosthetic components are placed on the prosthetic shaft and have sufficient stability and strength to provide support for the soft tissue of the cut stump. It is composed. At that time, the proximal edge of the prosthetic shaft is formed to be pulled up as high as possible to ensure that the cut stump is accommodated. In the lower leg shaft, the proximal margin extends, for example, medial and lateral to the knee condyle, and is deeply cut out in the tibial and patellar regions. A similar structure is obtained with the forearm shaft. On the thigh shaft, lateral elevations are formed to provide lateral stability.

Underlying this invention is the task of presenting an improved fabrication method for a large number of different artificial modifiers.

The present invention solves the problems posed by a method of making an artificial prosthesis, particularly an artificial orthotic device liner. The method is such that the artificial compensator is made from at least one material made at least partially using an additional material, the material is inserted into the support material in a fluidized state and then cured. It is characterized by that.

Along with various 3D printing methods, the 3D printing method developed by, for example, MIT and published under the keyword "Rapid Liquid Printing" also belongs to the additional production method. In doing so, the object to be made is made exclusively in a gel suspension or while the material is not yet cured or sufficiently crosslinked without chemically reacting with the material. It is produced in a container filled with another substance that is only used to mechanically support the material. The gel suspension is, in this case, the supporting material. In all of these methods, the production material is treated in fluid form, eg liquid. For example, in "high speed liquid printing", the liquid or gel-like fabrication material, both of which are considered fluid in this case, is into the gel suspension using a positioning device, eg, using a three-dimensionally movable nozzle. It is inserted at the desired position. Based on the density ratio between the fabric and the support material of the gel suspension and the high viscosity of the support material, the inserted fabric remains in their respective positions. In this way, the three-dimensional object "prints" by inserting the fabrication material into the gel suspension in the desired form at each desired position and then cross-linking, solidifying or curing in situ. "Get". When describing curing below, it also includes cross-linking or another reaction or modification of the properties of the material to be made, which results in increased shape stability or to obtain the desired state of the artificial modifier or part. .. Especially for flexible or elastic materials, the flexibility or elasticity remains retained after curing. Crosslinking is construed as hardening for the purposes of the present invention. The advantage over traditional 3D printing methods lies, among other things, in the many possible fabrication materials, including silicones that are cross-linked at room temperature available on the market. Another advantage is that it is possible to place three-dimensional objects directly in the printer's workspace without the need to stack them in layers, based on a process with gel suspension. Further, according to this method, the production speed can be increased, and thus the production cost can be reduced.

Fabrication materials are, for example, silicones, polyurethanes, thermoplastics, casting resins or other synthetic resins. For the fabric, it is merely important that the fabric can be treated and cured in a coatable form, i.e., fluid, eg liquid or otherwise injectable.

In this way, for example, artificial orthotic liners, artificial glove, insoles and other artificial prostheses are made from conventional silicones by molding easily, quickly and optionally individually. When thermoplastic materials are used, the mechanical stability and hardness that appears after curing can be achieved by this method with reinforcing elements such as artificial orthotic shafts, joint protectors, or splints for, for example, artificial prostheses. May be sufficient to make. The prosthetic device exterior and the prosthetic device decoration can also be produced in this way. In addition, prototype prostheses, such as prototype shafts or prototype decorations, can also be made.

By using additional fabrication methods, it is particularly easy to fabricate, for example, prosthetic decorations, especially foot wraps, ankle covers, or individually made patellas or individual knee caps with or without, for example, shaft fittings. can do. Such artificial prostheses can thus be formed, for example with waterproofness and / or some functionality, with higher mobility due to the bellows structure within the wrist joint region of the prosthesis, for example.

In a preferred embodiment, the fabrication material is supported and / or held in its place in the work space by the supporting material during curing. The fabrication material is preferably a self-curing material or a material that can be cured by increasing the temperature. When using self-curing materials, it is advantageous that there is no need to work with other curing means, such as electromagnetic irradiation or chemical additives. These advantages are also obtained by using a material that can be cured by increasing the temperature, which material is cured, for example, by adding heat rays.

In addition to the fabrication material that is inserted fluidly into the support material, fibers, especially continuous fibers, can also be inserted together. These fibers are applied at the same time as the production material and can be particularly surrounded by the production material. Those fibers preferably contain or are carbon fibers that reinforce the part to be made.

Preferably, the production material is composed of at least two components. Preferably, the mixing ratio of at least two components can be adjusted relative to each other. Particularly preferably the mixing ratio can be adjusted while performing the additional fabrication method. With this form, for example, a manufacturing material of a plurality of components, each of which is in a fluid state by itself, can be applied. At that time, each component itself is preferably configured so as not to cure or cure very slowly. However, when the two components come into contact with each other, a chemical reaction occurs, which results in the original fabric, which preferably cures quickly. Since changing the mixing ratio affects the physical and / or chemical properties of the material thus produced, the portion of the artificial corrector thus produced is almost stepless. It has different physical properties and may contain corresponding gradients.

In a preferred embodiment, the fabrication material is formed, for example, after curing so that its value has a shore hardness that depends on the mixing ratio. In this way, the high hardness region and the low hardness region are integrally manufactured with respect to each other so as to be directly arranged side by side in one method step, and it is not necessary to change the apparatus or the material used. It is sufficient to change the mixing ratio of at least two components, which can be done during the additional fabrication method.

In this way, a continuous change in material parameters or physical properties of the material to be made can preferably be achieved by continuously changing the mixing ratio. For example, a crus liner that is clearly made more elastic in the popliteal region than in other regions can be considered. Instead or in addition, complex gradients with respect to wall thickness that cannot or can only be made using prior art fabrication methods or, for example, the mold fabrication required for it. A part having the above is manufactured.

In a preferred embodiment, at least two different fabrication materials are used in the additional fabrication method. This is preferably done at the same time. The two different fabrication materials are then different in at least one property. Thus, for example, the fabrication material may be used in different colors to produce the desired optical effect and cosmetic impression. For example, by using a colored fabrication material, and also the label of the artificial modifier that is to be made, in the artificial corrector, or at least partially made using an additional fabrication method. Granted to at least one component. This is significant, for example, when the artificial compensator will be worn on the patient's body in a predetermined orientation. For example, if the prosthetic liner is equipped with an embedded electrode, for example to extract a myoelectric signal from the cut stump or to stimulate the muscle of the cut stump with an electrical signal or for plasma processing. It is important that the electrodes are reproducibly placed in the correct position on each cutting stump. This, of course, also applies to electrodes placed on orthopedic instruments that are worn over the patient's still-existing body. The use of markers in these cases may facilitate the patient to press an artificial prosthesis, such as an artificial orthotic liner, against a body part in the correct orientation. These labels are particularly easily made by using the method according to this embodiment of the present invention to color the production material of the additional production method to a different color and use it in different positions where the labels are placed. Will be done.

Further wear or breakage labels are made by using two different fabrics that are colored. For example, in an intact artificial remedial, if only the material of the first color is visible from the outside, the appearance of the second color, for example, the worn part must be replaced or the artificial remedial has a defect. A clear signal is given.

At least two different fabrication materials are preferably different in terms of their electrical conductivity. For example, ordinary silicone or polyurethane is electrically insulating, but the silicone or polyurethane can be electrically conductive by adding appropriate additives such as soot particles or metal scraps. From German Patent Gazette No. 102017126465, which has not been published in advance, a corresponding artificial compensator whose substrate is made of an electrically insulating material is known. The substrate can be made from the first making material, for example using an additional fabrication method. In the first production material, there is a conductive wire having a core made of a conductive elastomer, and the conductive wire has an electric insulating film. For example, this electrically insulating film in the form of a parylene film is used as an adhesive between a conductor made of a conductive elastomer and a substrate material. However, in the embodiment of the present invention, the substrate material can be treated in the form of the first fabrication material and the conductive elastomeric material of the conductive wire in the form of the second fabrication material, preferably simultaneously. In a preferred embodiment, both the conductive wire material and the substrate material, i.e. both of the fabrication materials described herein, are silicones, respectively. In this way, the elastic properties of the first fabrication material forming the substrate in the described examples are not affected by the conductive wire. No adhesive layer is needed as the two materials to be made cure at the same time. In this way, the two fabrication materials will be optimally bonded.

By the method described herein, therefore, at least one conductive wire, however preferably two or more of the conductive wires, can be placed within the fabrication material of the artificial corrector.

The fabrics used instead or in addition differ, eg, in their hardness and / or their elasticity after curing. Since these different fabrication materials are placed in different positions on the prosthesis, for example, in the case of an orthotic device liner, the bones that are very close to the outside of the cut stump are positioned and especially the areas that require buffering are particularly soft. It can be coated with a cushioning material. If the prosthesis liner is, for example, a prosthesis liner for a patient with a lower leg amputation, the area of the knee fossa can be made of a particularly elastic fabrication material to accommodate the high mechanical load due to several-fold elongation. Further, for example, in order to increase the longitudinal rigidity of the prosthetic device liner, but at the same time maintain the lateral elasticity, a depression can be created by using the low elasticity manufacturing material in the high elasticity manufacturing material. Further, by an additional fabrication method, it is possible to create a longitudinally expandable structure as described in, for example, German Patent Publication No. 102017106903 and used in a prosthetic device liner. The longitudinally expandable material has a negative Poisson's ratio. This is because stretching of the material in one direction does not result in shrinkage in a second direction perpendicular to this direction, unlike normal materials, and results in stretching in this second direction as well. Means. In particular, two-dimensional longitudinally expandable materials can advantageously be used within the liner. The structure required for this is particularly easy and cost-effective by the fabrication methods described herein, and is also fabrication with a large number of parts.

When different fabrication materials are used for different regions of the artificial dressing tool or different regions of the parts of the artificial dressing tool made by the additional fabrication method, the different fabrication materials may also be used sequentially. In this case, the device for performing the additional fabrication method preferably comprises multiple outlets, which are preferably coupled with containers for different fabrication materials so that different fabrication materials are directly present. Can be used sequentially and / or simultaneously.

Preferably, during the additional fabrication method, at least one fabrication material is combined with the separately crafted parts of the prosthesis. To that end, a separately manufactured component, which may be, for example, a coupling cap, a coupling adapter made of another material, eg, an electrode, a battery holder or another element, is subjected to an additional fabrication method within it. It is placed in the device and in the supporting material. In the "fast liquid printing" method, each separately made part is therefore placed in a gel suspension. The production material for the additional fabrication method is positioned in contact with the separately manufactured parts during the additional fabrication method, so that the separately produced component and the fabrication material during curing of the fabrication material. Leads to material bonding with. Of course, the fabrication material can also be arranged instead or in addition to lead to shape bonding after the fabrication material has been cured.

Alternatively or additionally, individually made parts can be inserted into the already printed but not yet cured material. That is, for example, after the prosthetic liner has been made according to the described method, cables or reinforcing fibers or the like can be placed in the walls of the liner, and then the cables or reinforcing fibers are cured. It is bonded to the material to be made by material bonding and / or shape bonding.

Prosthetic liners often have a so-called liner cap in the distal region. The liner cap can be used to create a mechanical bond to the prosthetic shaft. Electronic components, sensors, pneumatics, hydraulics or other elements may also be placed within the liner cap. The liner caps are made separately and can be combined with the making material during additional fabrication methods as separately made parts. The same applies to electronic components such as sensors, electrodes or other elements. They can also be considered separately manufactured parts.

In a preferred embodiment of the method, at least one object is inserted into the supporting material and the fabric is printed on the object during the additional fabrication method. The fabrication material is therefore inserted into the support material in a fluid state so as to come into contact with the object inserted into the support material. At that time, when the production material is cured, material bonding and / or shape bonding preferably occurs between the inserted object and the material to be cured. That is, for example, a portion made of an elastic material of an artificial prosthesis, such as an artificial device shaft, can be inserted into the support material and then the pad and / or cushion can be printed by an additional fabrication method. The pad or cushion is then at least partially, but preferably completely made from the fabric. The fabrication material is fluidly inserted into the support material so that it comes into contact with the prosthetic shaft, which is also located within the support material.

This method is particularly advantageous when precise adjustment between the two parts is required or desired. That is, for example, one artificial device decoration, that is, a synthetic resin exterior surrounding the original artificial device can be printed directly on the artificial device. That is, for example, a prosthesis or another artificial prosthesis can be inserted into the support material, eg, submerged. The portion made by the additional fabrication method of the artificial corrector can be printed directly on the inserted part. Functionality, such as individual buffering properties, can also be created during the additional fabrication process. The prosthesis and / or the prosthesis exterior surrounding the original prosthesis can be made, for example, from different materials in different positions so that different cushioning properties occur.

Furthermore, in particular, artificial orthotic liners often include, but are not limited to, these artificial prostheses, a fibrous layer or other fibrous component. In this case, this fibrous element is also considered to be a separately made part and can be combined with the material made during the additional making method.

Orthopedic devices often serve to apply pressure to a given body position, for example to support joints or reduce the load on bands and tendons. Indenters are preferably used for this purpose, and these indenters are often made of silicone, which allows the orthopedic appliance to apply pressure to the desired position, eg, after tightening an additional belt. Placed on the body of. Also, such indenters can be made from the materials made by the types of methods described herein. In doing so, the fabrication material is preferably coupled to a separately manufactured component, eg, a substrate of a shaping instrument composed of fibers.

As described above, the parts and elements that will be bonded to the production material may already be inserted into the support material when the production material is applied in a fluid state. However, this is only possible in the case of flexible elements such as fibers. This is because these flexible elements do not have or have only a small amount of shape stability. Therefore, it has proved advantageous to fabricate the liner or other prosthesis component as a closed volumetric space. There is a supporting material inside the volume space. On these closed-formed liners, the fibrous layer can be applied particularly easily due to the resistance caused by the confined support material, without the need to make molds or tools. If a fibrous layer is applied, the liner is opened at the proximal end and the contained supporting material can be removed. The fiber layer to be imparted can be attached in advance, for example. In addition to or instead of imparting fibers or other materials, it is advantageous to mold another part, eg, a prosthetic shaft, directly on the liner in certain circumstances. Also for that reason it is advantageous for the liner to be able to withstand the load, which can be achieved specifically by the methods described above.

To enhance the effectiveness of the confined support material, especially in the case of water-based support materials, the support material is confined within it by freezing the closed and formed portion of the prosthesis. The resistance caused by can be enhanced. This makes the supporting material stiff and able to receive the forces acting on the application of the fiber layer, especially during application, and preferably does not deform the still closed cooled and frozen liner. Instead of the closed and formed different forms of the portion made by the additional fabrication method of the prosthesis, there may be inlets and / or outlets specifically with or without valves, through which. For example, the included support material can be removed from the otherwise closed portion of the artificial corrector. If high shape stability of this part is desired, for example through the piping associated with the inflow, a medium, eg air, is introduced into the otherwise closed part of the artificial corrector, thus requiring it. The pressure to be applied can be increased. After applying the fibrous layer, the closed portion of the artificial corrector can be opened and, in some cases, the supporting material contained therein can be removed.

Alternatively or in addition, a reinforcing element may be inserted into the otherwise closed portion of the prosthesis. The reinforcing elements are formed so as to be in particular contact with each other by removing or draining the fluid from the volumetric space, or at least to enhance their contact by removing or draining the fluid. In a very simple embodiment, the reinforcing element can be particulate matter, such as sand. In this case, for example, if air is removed or expelled from a reinforcing element, a volumetric space filled with particulate matter, the individual reinforcing elements will come into contact or reinforce this contact with each other. Thereby, a strong shape can be formed to support the besieged and / or the included prosthesis.

In the additional fabrication method, the wall thickness of the artificial corrector can be changed in continuous or discrete steps so that at least one bulge, depth, thickness, taper and / or retaining is produced.

Advantageously, the additional fabrication method produces an artificial modifier and / or component having at least one hollow space. In that case, it is basically set to create a hollow space by transferring the region of the gelled suspension using the fabrication material. But instead or additionally, the hollow space is created by first removing the material to be made as a solid material and then adding to the material the auxiliary material forming the corresponding hollow space in the still liquid state. .. At that time, the auxiliary material may be a gas or a liquid, for example, or may be a gel-like suspension used, and stays in the part after the part is manufactured to create, for example, an air cushion. It can be obtained or removed again from the cured part. The hollow space, particularly the hollow space created as described above, has various properties and can meet various problems. This hollow space may be a closed hollow space and may have an opening or a punched hole. That is, for example, a structure in which a hole is punched can be produced, and the structure is formed in a honeycomb shape, for example, which is useful for mechanical strength.

However, if at least one hollow space is a partitioned hollow space, the hollow space, for example, as an air cushion, cushions the wearer of the artificial corrector to a particularly sensitive area of the body in this way. Can be used to improve wearing comfort. The air cushion thus produced may be formed, for example, with a connection terminal for pumping air into or out of the air cushion. Thus, the pressure in the air cushion can be tailored to the individual requirements by adjusting the expansion of the air cushion as well. That is, for example, fluctuations in the volume of the cutting stump can be taken into consideration. If, for example, the electrode is on the side of the air cushion facing the body, the electrode is pressed against the wearer's skin using contact pressure, and the contact pressure is regulated and optimized by such a bulging air cushion. obtain.

Such air cushions can be used to apply the necessary and advantageous pressures to treat scar tissue, eg, during burn treatment, more extensively and / or depending on the area. The created hollow space may exist, for example, in the form of a path containing a refrigerant for cooling the body part in contact with the artificial corrector. Also, for drug transport, a route can be used in the additional fabrication method such that it is created as a hollow space from the fabrication material.

Alternatively or additionally, the at least one hollow space may be at least partially, but preferably completely filled, with at least one filling material during the additional fabrication method. At that time, preferably at least two hollow spaces are filled with different filling materials. Especially in the case of at least two hollow spaces, preferably the two different filling materials already introduced into the hollow space during the additional fabrication method are composed of different components that chemically react with each other, such as silicone. obtain. Such ab-silicone is known from the prior art, and as soon as the two components come into contact with each other, the material is cured or crosslinked or stabilized. These silicones fill the hollow space created, for example, between the cut stump and the artificial device liner when a standard size liner is used, and the inner contour of the liner is individually defined to the body shape of the wearer of the artificial prosthesis. Can be used to align with. The mixed but still liquid material is then sealed within the already cured encapsulation and wraps around the stump as a liquid intermediate layer without direct contact with the stump. The liquid material takes the geometric shape of each stump and cures in this shape.

The device for performing such a method is therefore equipped with at least three output nozzles through which different materials can be output. While the fabrication material is inserted into the desired shape from that one output nozzle, eg into the gel matrix, different filling materials are introduced from the other output nozzles into the hollow space thus created. .. If the two filling materials must later react to each other, it is only necessary to pull the bond wall between the two hollow spaces apart.

Alternatively or additionally, the hollow space is filled only after the fabrication material has hardened. For example, from the unpublished German Patent Publication No. 10201811442, an artificial prosthesis having a hollow space filled with a filling material after curing of each material, in particular an artificial orthotic device liner, wherein the wall of the hollow space is composed of it. Are known. Thereby, mechanical stability can be enhanced here so that, for example, a support device or support structure can be made within the substrate of the artificial compensator. Corresponding embodiments of the methods described herein, a plurality of parts of an artificial corrector can also be made from at least one making material by an additional making method. Since each of these parts comprises a hollow space in the form of, for example, a hose or a tunnel, and thus can be coupled to each other, these different hollow spaces are in contact with each other and are particularly fluidly technically coupled to each other. .. In this way, the hollow spaces are together filled with each structuring material. Of course, other materials, such as cooling or radiating materials, can also be introduced to warm or cool the artificial device and thus to enhance the wearing comfort of the artificial prosthesis to the wearer.

In a preferred embodiment, the fabrication material used in the additional fabrication method is an elastic material when finally cured. Especially in this case, but also in the case of other fabrication materials, it is advantageous to fill the hollow space created during the additional fabrication method with the foam material. To that end, a foamable material is inserted into the finished hollow space, which in turn foams, preferably completely filling the hollow space. Therefore, in principle, each foamable material known from the prior art is used, and in that case, a material having a plurality of components is particularly used. At that time, at least two components of the material to be foamed are inserted into the hollow space. The components then react with each other and begin to foam.

An artificial prosthesis such that the prosthesis holds the artificial prosthesis, for example, a vacuum liner, that is, the artificial orthotic shaft on the artificial equipment liner by negative pressure, that is, by drawing an intermediate space between the artificial equipment liner and the artificial equipment shaft into a vacuum. If so, by incorporating a hollow space in the sense of a vacuum path into the artificial prosthesis, which in this case could be a liner and / or an artificial device shaft, in the intermediate space between the artificial device shaft and the artificial device liner. It is advantageous to be able to generate negative pressure as evenly as possible.

Advantageously, from at least one fabrication material using additional fabrication methods, at least one pneumatic element and / or at least one hydraulic element, preferably at least one volumetric reservoir, at least one sealing lip, at least. One valve and / or at least one pump is made. At that time, the hydraulic element and / or the pneumatic element is preferably manufactured integrally with another part of the artificial compensator. Such parts are used in a series of artificial compensators and are thus easily and cost-effectively and optimally positioned and finished. For example, in a vacuum liner, the sealing lip used to hermetically seal the space between the prosthesis liner and the prosthesis shaft that should be evacuated to the outside is generally located outside the prosthesis liner. Will be done. A plurality of sealing lips may also be placed on the outside and / or inside of the prosthetic liner. The method described herein can then be used to fabricate the entire liner in an additional fabrication method, where at least one fabric is the liner material. The material can be, for example, silicone or polyurethane. In this case, the sealing lip can be made at the same time as the remaining liner during the additional fabrication method, thus providing the optimum adhesion between the sealing lip and the liner substrate caused by material bonding. Instead, the sealing lip can also be placed on the substrate of the liner, which is finally made separately, at a later stage. It is especially true that standard liners are used for patient treatment, but the optimal position of the sealing lip on the outside of the liner depends, for example, on the length of the cut stump, and thus for the wearer of the prosthesis. This is advantageous when it must be individually aligned. Individual matching can be done by additional fabrication methods.

In a series of prosthetic liners, for example, an air tube with a lead valve or a one-way valve is used within the liner to use the lifting motion between the prosthetic liner and the prosthetic shaft that occurs during walking. The volumetric space is pumped out and evacuated. These pneumatic elements can be incorporated into a liner substrate that can be made from at least one making material using the methods described herein. U.S. Patent Publication No. 2017/0143519A1 relates to a prosthetic device liner comprising a one-way valve and a flow-in air permeable material forming a flow path. The pump chamber may be pumped between the outer liner and the inner liner.

Similar to the sealing lip, for example, the anchoring elements for mechanically fastening the two parts of the artificial corrector to each other are produced separately or simultaneously by an additional fabrication method, especially by a high speed liquid printing method. It can be molded to attach to the substrate of the liner, for example. High-speed liquid printing methods are described, for example, in US Patent Publication No. 2018-281295A1.

In a preferred embodiment, the measurement data is first detected from the patient in the method and the measurement data is made available for electrical and / or electronic control. This control is arranged to control the additional fabrication method at least also based on these measurement data. This is particularly advantageous for artificial dressings that are individually tailored to the patient. In particular, the prosthetic shaft and prosthetic liner can thus be made quickly, easily, cost-effectively, and yet individually for each patient in a single step. Various methods are known in the prior art for detecting measurement data. That is, for example, the body part of the patient who comes into contact with the artificial corrector can be detected by an optical scanner and measured in a three-dimensional direction. The measurement data so obtained are made available for electrical and / or electronic control. At that time, the cut stump or body part to be measured can be introduced, suspended or inserted into a special device, so that it becomes dominant and of course when the prosthesis or orthotic device is pressed. Pressure ratios that affect the geometry of body parts and cut stumps can be considered.

Since the standardized shape and / or dimensions of the artificial corrector according to the embodiments described herein in this method, in conjunction with the described fabrication of the individually matched artificial modifier, there is no need to fabricate the mold. It is produced more easily and cost-effectively than the prior art. The fabrication material is readily placed within the supporting material and cured or cured in the desired arrangement and distribution.

In addition, the artificial corrector can be semi-individually finished. In doing so, for example, the standard shape stored in digital form is individually adjusted using the individual dimensions taken from the patient. These finishes can be done easily and quickly using additional fabrication methods. That is, for example, the position and / or size of the sealing lip on the outside of the prosthetic liner can be individually tailored to the patient. Also, prosthetic gloves can be individually finished, for example with respect to their length and / or width, whereas standard dimensions are otherwise used.

In a preferred embodiment of the method described herein, for example, the surface of the artificial modifier or the feel or structure of the parts of the artificial modifier made by the additional fabrication method is affected and in some cases partially. Can be changed. That is, for example, in the proximal region, a prosthetic device liner having a different feel or structure from the distal region can be made. In this way, for example, the dressing can be facilitated. Further, for example, the adhesion property can be changed by imparting a surface structure at least partially, in some cases, to the inside of the artificial device liner manufactured by the additional manufacturing method. The above-mentioned vacuum path for the supply of negative pressure to the prosthetic device liner also individually aligns the negative pressure distribution in the negative pressure liner and may be optimally selected for the comfort of the patient's fit. For that purpose a vacuum path is inserted into the artificial compensator, which is preferably done during the additional fabrication method. This vacuum path allows the volumetric space to be evacuated, in which the negative pressure distribution is individually adjusted by the shape and design of the path.

In particular, by using various fabrication materials, the shore hardness of each fabrication material to be cured is further selected, for example. That is, for example, by using two different manufacturing materials, a wear-resistant outer layer and a soft cushioning core material can be manufactured at the same time. In addition, the fabrication material is placed within the foam structure, which allows the foam structure to create a breathable wall.

Preferably the prosthesis is an orthotic device liner for use within the orthotic device shaft, which has a containment space with a distal end and a proximal edge. The containment space is formed so that a cut stump to which a prosthetic liner is applied can be introduced into the containment space and accommodated within the containment space. The method is to secure the sealing lip curve to the outside of the prosthesis liner, corresponding to the curve of the height contour of the prosthesis shaft or based on the available well-known anatomical data of the cut stump. Includes placing the sealing lip on the outside of the prosthesis liner along a fixed sealing lip curve using at least one additional fabrication method. This also includes making a liner or liner substrate in which the sealing lip is integrally molded.

The height contour is the curve of the proximal edge of the prosthesis shaft in the proximal and distal directions, forming the curve of the proximal termination structure of the prosthesis shaft. After determining the height contour, the sealing lip curve is fixed to the outside of the prosthesis liner to correspond to the height contour curve of the prosthesis shaft. The sealing lip is placed outside the prosthetic liner along a fixed sealing lip curve. This is done using at least one additional fabrication method.

The sealing lip curve follows the height contour of the proximal edge of the prosthesis shaft in the pressed state and is formed to correspond to the termination structure at the top of the prosthesis shaft. At that time, the position of the sealing lip attached to the artificial device liner is such that when the artificial device liner pressed against the cut stump is completely introduced into the artificial device shaft, the sealing lip is attached to the artificial device shaft. It is fixed so that it is located distal to the proximal edge. The curve of the sealing lip corresponds to the proximal termination structure of the prosthesis shaft so that the prosthesis liner and prosthesis shaft run as proximally as possible with the prosthesis liner attached. Can be placed, thereby expanding the volumetric space to be drawn into the vacuum between the prosthesis liner and the prosthesis shaft as compared to the prior art form. Thereby, the force for holding the prosthesis shaft on the prosthesis liner is increased, and it is not necessary to reduce the pressure in the volumetric space drawn by the vacuum as compared with the conventional form. At the same time, the force required to hold the prosthesis shaft on the prosthesis liner will be distributed as widely as possible and thus evenly to the cutting stump.

Geometry individually aligned to the proximal edge of the prosthetic shaft and the corresponding curves of the sealing lip maximize the mechanical quality of the interface and reduce the load on the stump, especially on the cut stump. To. This enhances user comfort and creates a secure bond between the prosthetic shaft and the stump.

The sealing lip curve can be fixed, for example, based on the presence or calculation of the proximal edge of the prosthetic shaft, especially the curve in digital form. The well-known curve of the proximal edge of the prosthesis shaft is used as a reference for the sealing lip curve, the sealing lip curve correspondingly fixed. Similarly, fixation of the sealing lip curve may be based on the scanned stump, or other otherwise obtained data on the shape and / or properties of the stump, or its anatomical data. The biostructure in digital form or calculated can be used as a reference for the prosthetic liner to be made and even for the prosthetic shaft to be made. The prosthesis liner, and in some cases the prosthesis shaft, is also digitally shaped into a nearly stump model or digital image. Its shape roughly corresponds to the outer contour of the stump and is aligned with the prosthetic shaft for a load-reducing region or compression region to offset volume fluctuations, with an addition to the cushioning body attached to the liner. Accompanied by. The prosthesis liner can also be designed based on a stump model, or a digital image of the stump and / or prosthesis shaft, and converted into a digital data set. In doing so, the sealing lip curve can be determined based on anatomical data without using existing or calculated prosthetic shaft data sets.

In another embodiment of the invention, the height contour of the proximal edge of the prosthetic shaft is detected prior to fixing the sealing lip curve. The height contour, that is, the curve in the proximal and distal directions of the proximal edge of the prosthesis shaft, forms the curve of the upper termination structure of the prosthesis shaft. For example, by a scanning method in which the height sensor travels along or parallel to its proximal edge and assigns height data to ambient coordinates, or by non-contact measurement, such as an optical measurement method or otherwise. Scanning detects the height contours of the already physically present prosthetic shaft, and also based solely on the data on the prosthetic shaft, especially the data on the prosthetic shaft to be made further. It can be. If a 3D model or data set to which the prosthetic shaft will be made will already exist, the encapsulation lip curve can be fixed based on these data to make the prosthetic liner. ..

In order to prevent the sealing lip from protruding proximally beyond the proximal edge of the prosthetic shaft when the prosthesis liner is attached and fully deployed, the sealing lip is preferably the prosthetic shaft. Placed on the prosthesis liner offset distally to the proximal edge of the. When detecting the height contour, preferably not only the proximal / distal curve of the proximal edge of the prosthesis shaft, but also the distance from the distal end of the containment space to the height contour is detected. From such a detected distance, when the prosthesis liner attached to the cut stump is introduced into the prosthesis shaft, how far from the distal end of the prosthesis liner is the proximal edge of the prosthesis shaft to the prosthesis. It is possible to specify whether it will be adjacent to the liner. Starting from this line, the sealing lip is preferably placed on the prosthetic liner with a distal shift. Distal displacement or movement away from the proximal edge of the prosthesis shaft provides a safety zone, which offsets the deviation of the prosthetic liner's pre-configured orientation, eg, at the stump. be able to.

The acquisition of the height contour curve is done in the proximal and distal directions, preferably taking into account the total length of the prosthesis shaft, and thus the distance from the distal end of the prosthesis liner to the sealing lip curve. Alternatively or supplementarily, the perimeter contour of the proximal edge of the prosthetic shaft is preferably obtained along the perimeter. Therefore, the extension of the sealing lip in the radial direction, that is, the distance from the edge of the sealing lip on the outer side in the radial direction to the outside of the prosthetic device liner can be matched for each patient. The stretch of the sealing lip is preferably not constant along the perimeter and varies according to the estimated distance from the inside of the prosthetic shaft to the cut stump and the outside of the liner mounted on the cut stump.

The sealing lip is preferably located along the perimeter of the prosthesis liner in the proximal and distal directions equidistant to the proximal edge of the prosthesis shaft, i.e. the height of the proximal edge of the prosthesis shaft. It runs at least almost identical to the contour, but preferably exactly identical.

The sealing lip is preferably placed within the sealing lip region. The sealing lip area is wider than the sealing lip itself in the proximal and distal directions, and the set where the sealing lip can be placed and fixed on the outside of the already prefabricated prosthetic liner. It is an attached area. The sealing lip region aids in facilitating manufacturing and, in at least one additional fabrication method, places the sealing lip itself within a predetermined region in the proximal and distal directions outside the prosthetic liner. Enables. The proximal and distal boundaries of the encapsulating lip region preferably depend on the height contour of the proximal edge of the prosthesis shaft, and particularly preferably correspond to that height contour.

The sealing lip region is the transition from the sealing lip to the outside of the prosthesis liner, i.e. the base of the sealing lip located outside the prosthetic liner, preferably twice as wide as the sealing lip. ..

The height contour, or height contour and perimeter contour of the prosthesis shaft is preferably optically detected. The detected image data forms the basis for, for example, a digital 3D model, and a data set is created for or from the 3D model. Based on the 3D model data set, the encapsulation lip curve, or encapsulation lip curve and encapsulation lip shape, is fixed according to the detected height contour, or the detected perimeter contour and height contour. .. Detection of height contours can also be performed from existing data, such as a 3D model of the shaft, without the need for a physical prosthetic shaft. For example, if the prosthesis shaft is made based on a data set of limb stumps, eg amputated stumps, in an additional orthotic method, the internal contour of the prosthesis shaft may vary in volume and in some cases artificial. It almost follows the outer contour of the stump with the added material thickness of the prosthetic liner.

If the prosthesis shaft is not made, for example, based on the stump itself or digital data taken from the gypsum model of the stump, preferably the internal contour of the existing prosthesis shaft is optically or otherwise detected. Stored in the computer system. Sealing on the outside of the prosthesis liner based on a comparison of the outer contour of the stump and the inner contour of the prosthesis shaft with the height contour of the proximal edge of the prosthesis shaft, which is also within range of the 3D model. The stop lip curve is fixed. This, of course, also includes the location of the sealing lip on the outside of the prosthetic liner. In addition, preferably, the height, shape and thickness of the prosthesis liner or the substrate of the prosthesis liner are fixed and processed as a data set for fabrication in at least one additional fabrication method. Encapsulation lip curves and encapsulation lip heights and / or encapsulation lips matched to height contours and / or perimeter contours within the scope of at least one additional fabrication method, eg, within the range of high speed liquid printing methods. A prosthetic liner with a thickness is produced.

The curve of the sealing lip can be determined directly from the anatomical data, for example based on a scan of the stump. Since the height contour and perimeter contour of the shaft can be determined from the curve of the sealing lip initially considered appropriate or optimal, the sealing lip curve is relative to the curve of the proximal edge of the prosthetic shaft. Used as a reference dimension. Alternatively, the height and perimeter contours of the shaft are similarly obtained from the anatomical data of the scan. As a result, the curve of the sealing lip corresponds to the curve of the height contour of the prosthesis shaft, and the sealing lip curve is created and fixed according to the initially fixed height contour of the prosthesis shaft. Or is the height contour of the prosthesis shaft created and fixed according to the initially defined sealing lip curve, or is the sealing lip curve and height contour anatomical independently of each other? It is irrelevant whether it is created and fixed based on the target data, for example, based on a digital 3D stump model.

The height of the sealing lip is fixed according to the distance obtained between the inside of the prosthesis shaft and, optionally, the outside of the stump to be introduced, on which the base of the prosthesis liner is mounted. obtain.

Using the prosthetic device liner thus produced, a system is preferably formed from the prosthetic device shaft and the prosthetic device liner. At that time, the prosthesis shaft has a storage space for the stump to which the prosthesis liner is applied. The prosthetic shaft has a distal end and a proximal edge. The proximal edge of the prosthesis shaft has a height contour and a perimeter contour. At least one sealing lip is formed or secured on the outside of the prosthesis liner facing the prosthesis shaft. At that time, the sealing lip curve of at least one sealing lip corresponds to the curve of the height contour of the artificial device shaft with the artificial device liner fully inserted. The encapsulation lip does not have to terminate in the same plane as the proximal edge of the prosthesis shaft, but rather the encapsulation lip shifts distally from the proximal edge of the prosthesis shaft according to the termination contour to the prosthesis liner. It is set to be arranged.

The prosthesis shaft is formed to close the wall distally to at least one sealing lip with the prosthesis liner being pressed fully introduced to create the widest possible interface area. Therefore, a negative pressure can be generated on the widest possible surface. Thereby, the required holding force is generated and transmitted onto the cutting stump.

The prosthetic shaft is preferably formed to be shape stable to provide sufficient stability to accommodate the stump with liner and additional prosthetic components, such as the placement of the prosthesis. Has been done. At least one sealing lip is fixed or formed on the substrate of the prosthesis liner and can have uneven heights along the perimeter of the prosthesis liner, i.e. the outer contour of the stump and the prosthesis shaft. Various radial outward protrusions can be made away from the outside of the prosthetic liner to offset shape fluctuations or shape differences with the inner contour.

In another embodiment of the invention, at least one sealing lip is fixed or formed on the substrate of the prosthesis liner and is unevenly heighted along the perimeter of the prosthesis liner, i.e. from the outside of the prosthesis liner. It is assumed to have uneven extension outward in the radial direction. Thereby, the difference in radial distance between the outside of the substrate and the inside of the prosthesis shaft in the pressed state can be offset. This ensures that the sealing lip is always adjacent to the inner wall of the prosthetic shaft when the stump with the liner is inserted. Different heights, or different radial bulges, along the perimeter of the prosthesis liner are obtained, for example, by comparison between the scanned inside of the prosthesis shaft and the scanned outside of the stump or a 3D model. ..

The sealing lip curve is preferably not in a plane and thus is not linear and draws a spatial curve with irregular spacing above the perimeter with respect to the distal end of the prosthesis liner or prosthesis shaft.

The prosthetic device liner for the above system has at least one sealing lip formed or fixed to the outside of the prosthetic device liner, the sealing lip forming a sealing lip curve in the form of a space curve. The sealing lip curve of at least one sealing lip corresponds to the curve of the height contour of the proximal edge of the prosthetic device shaft into which the prosthetic device liner pressed against the stump will be introduced. It is formed like this.

The present invention further solves the problems posed by artificial prostheses made or can be made by the methods described herein, in particular artificial device liners.

Some embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

The drawings show:

It is a schematic diagram of a prosthetic device liner with different components. It is a schematic diagram of a prosthetic device liner with different design elements. FIG. 3 is a schematic diagram of a prosthetic device liner with different surface structures. FIG. 3 is a schematic diagram of a prosthetic device liner with different material structures. It is a schematic partial schematic diagram about the component part to be manufactured by the method by the Example of this invention. It is a schematic diagram of a different custom-made manufacturing method. It is a schematic diagram of a partial standard artificial equipment liner and a standard artificial equipment liner. It is a prosthetic device liner with a single display. It is a system consisting of an artificial device shaft and an artificial device liner placed therein. It is a schematic diagram of the manufacturing method of a different aspect.

FIG. 1 shows the prosthetic device liner 2 produced according to the embodiment of the present invention in the central region. The prosthetic device liner 2 is provided with an opening 4 in the proximal region and a liner cap 6 in the distal region. A small cutout, limited by a dashed line, shows different components that may be placed on the prosthesis liner 2.

In the upper left, separately made parts are shown, for example, in the form of a cushion 8 and an electrode 10 surrounded by a substrate of the prosthetic device liner 2 and a material 12 thereof in the illustrated embodiment. In the box below it, a form is shown in which two different materials are processed simultaneously via two sources 14. In this way, for example, a fabrication material having a hardness higher than that of the reinforcing element can be inserted into a softer fabrication material, which is, for example, a liner material for the substrate of the artificial device liner 2.

The bottom box on the left shows the sealing lip 16, even if the sealing lip is formed as a separately made part, for example, with the making material 12 printed on it with an additional fabrication method. good. Preferably the substrate of the liner 2 and the encapsulating lip 16 are made together in a single manufacturing step, i.e., an additional manufacturing method. In addition, the substrate of the prosthetic liner 2 may also be a separately made part on which the sealing lip 16 is printed. The position box 18 merely illustrates, by way of example, that the illustrated components can be placed in different positions on the prosthetic liner 2.

In the upper region on the right side of FIG. 1, it is shown that the fabrication material 12 is in the form of a knob 20 which can be, for example, a anchoring element. Further, this can be produced without any problem by the method according to the embodiment of the present invention. The knob 20 may then be formed as a separate component on which the fabrication material 12 is printed during the additional fabrication process. Alternatively or in addition, the knob 20 may also be made from the fabrication material 12 or a second fabrication material in an additional fabrication method. Preferably, the substrate of the liner 2 and the knob 20 are made together in a single manufacturing step, that is, an additional manufacturing method.

In the lower right of FIG. 1, it is shown that the connecting element 22 is printed on the fabrication material 12. Through such a connecting element 22, for example, the cable 24 may be connected to the conductive wire 26 inside the fabrication material 12. This conductive wire may be connected to, for example, an electrode (not shown in FIG. 1).

FIG. 2 shows a prosthetic device liner 2 with various optical elements, the optical elements of which can be made by an additional fabrication method with the colored fabrication material 12. A marking line 28 extends from the opening 4 to the distal liner cap 6, and the marking line allows the artificial prosthesis, i.e., the artificial orthotic device liner 2 in the illustrated embodiment, to be pressed in the correct orientation of the artificial prosthesis. It will be easier for the wearer. Of course, the marker line 28 does not have to run from the proximal opening 4 to the distal liner cap 6.

Within the area to the left of the prosthetic device liner 2, a design element 30 that substantially meets the cosmetic challenges is shown. That is, the design element may be formed, for example, as a design that can characterize the artificial corrector as being derived from the manufacturer.

The third optical element is the wear marker 32, which is composed of a similarly colored fabrication material. Such a wear marker 32 can be produced, for example, by forming the substrate of the artificial device liner 2 with a plurality of layers. This means that in the additional fabrication method, a plurality of fabrication materials that are different at least in terms of color are used. If the outer layer of the prosthesis liner 2 is missing or worn, a different color of each underlying layer can be recognized, and that other color acts as a wear marker 32.

FIG. 3 shows a prosthetic device liner 2 having three schematic position boxes 18 which may represent the positions of different elements merely by way of example.

Various structures are shown on the right. Inside the topmost box is shown the outside of the prosthesis liner 2 having regions 34, 36 with different feels. The surface of the prosthetic device liner 2 in the edge region 36 is structured and formed, whereas the central region 34 has a smooth surface.

The box below shows a vacuum path 38 inserted in a groove into the side wall of the prosthesis liner 2 during the additional fabrication method. Due to these vacuum paths, the negative pressure generated between the prosthesis liner and the prosthesis shaft (not shown) is drawn into a vacuum when the prosthesis liner 2 is pressed against it.

The fiber layer 40 is shown in the bottom region of FIG. During the additional fabrication method, the fabrication material 12 is applied onto the fiber layer using the outflow nozzle 42.

In contrast, FIG. 4 shows the prosthetic device liner 2 with a schematic diagram of the different material structures. The upper left region of FIG. 4 shows different types of hollow spaces that may have different functionalities. On the left side, a partitioned volumetric space 44 that acts as a cushioning cushion is shown. In a different central region, a volumetric reservoir 46 with an inlet 48 and an outlet 50 is shown. The inflow port 48 has a reed valve 52 that acts as a one-way valve. The volumetric reservoir 46 with an inlet 48 and an outlet 50 may be, for example, part of a hydraulic or pneumatic system. The volumetric reservoir 46, the inlet 48, the outlet 50 and the one-way valve 52 can also be made from the making material 12 during the additional fabrication method. In the right region, there is a path 54 that can be used, for example, for cooling purposes.

The regions below it schematically show that different regions of the prosthetic device liner 2, all of which may be made from the fabrication material 12, may have different shore hardness. In the bottom area, the side wall of the prosthesis liner 2 is shown in cross section. You can see the different thicknesses that the liner can have at different positions. Different thicknesses can be produced in continuous or discrete steps with additional fabrication methods.

The upper region on the right side of FIG. 4 schematically shows that the fabrication material 12 can be fabricated, for example, in the form of a foam, eg, a silicone foam. In the area below it, a so-called hybrid material, which is composed of different fabrication materials 12, is shown. In doing so, it may be a shape junction between the individual fabrication materials 12, as in the left portion, while the right portion uses multiple layers of different fabrication materials, the layers of which are joined together in a material junction. On the other hand, they are combined. The methods according to the embodiments of the present invention can be used to fabricate such hybrid materials in a single fabrication process, i.e., an additional fabrication method.

FIG. 5 schematically shows an additional fabrication method in the center. At that time, the illustrated embodiment deals with a high-speed liquid printing method developed by MIT. As indicated by the arrow 56, the outflow nozzle 42, which freely moves in all three-dimensional directions, ejects the fabrication material 12 and inserts it into the support material at a desired position. The products shown around the central region in FIG. 5 show a variety of possible artificial modifiers that can be made in this way. For example, an insole 58, an artificial device liner 2, an artificial device shaft 60, and, for example, an artificial hand glove 62 used for packaging an artificial hand.

FIG. 6 schematically shows that a separately molded prosthetic liner 2 with a proximal opening 4 and a distal liner cap 6 can be made. This can be done, on the one hand, by measuring the cutting stump 66, for example using a tape measure 64 or another conventional measuring method. Alternatively or additionally, as in the upper part of FIG. 6, the cutting stump 66 can be measured contactlessly using a scanner 68. Regardless of the measurement method used, the acquired measurement data is made available for electrical and / or electronic control, and those data control the production equipment used in the additional production method.

FIG. 7 shows, in the right region, a known prosthetic device liner 2 with standard dimensions and shape. Similarly, the left portion shows the prosthetic device liner 2, however, with the sealing lip 16 arranged. The sealing lip 16 shown by the dashed line schematically indicates that the sealing lip can be individually placed on the substrate prosthesis liner 2 at various different positions.

FIG. 8 shows a prosthetic device liner 2 with a proximal edge 70 and a distal end region 72 in a single display. The distal end region 72 is formed closed and the proximal edge 70 surrounds the insertion opening. The prosthetic device liner 2 has a substrate 74 with an outer side 76 and an inner side 78. The substrate 74 is flexibly, preferably elastically formed at least in the circumferential direction. The inner 78 of the substrate 74 is preferably composed of an adhesive polymer, such as silicone. Alternatively, the inner 78 may be completely or partially covered with an adhesive thin film. The thin film may be formed, for example, from silicone or another polymer that adheres to the skin. The outer side 76 of the substrate 74 may be similarly composed of an elastomer, or at least partially coated with an elastomer. Similarly, fibers may be applied to the outer 76 to equalize the pressure in the intermediate space between the prosthesis liner 2 and the prosthesis shaft (not shown). Alternatively or supplementarily, a ridge or groove may be placed on the outer 76 to allow fluid technical coupling over the entire longitudinal extension, i.e., distal to proximal and around. , Formed or inserted or imparted.

A sealing lip 16 is arranged on the substrate 74, and the sealing lip is placed between the proximal region and the distal region of the prosthetic device liner 2 in a state of being introduced into the prosthetic device shaft (not shown). Create a seal. The sealing lip 16 may be made of an air impermeable material or may be correspondingly coated so that air does not pass through the sealing lip 16. The sealing lip 16 may be composed of, for example, silicone or polymer, or may be coated with such a material. The sealing lip 16 is preferably made integrally with the substrate 74, for example using a high speed liquid printing method, within the scope of at least one additional manufacturing method. The distal region of the sealing lip 16 on the outer 76 of the substrate 74 may comprise a structured surface that allows pressure distribution to regions separated from each other. Structuring can be done, for example, as a fibrous material that can be glued or laminated, or through grooves and / or ridges on the outside 76.

Since the sealing lip 16 projects radially from the substrate 74 and is preferably elastically formed, the sealing lip 16 has its outer side facing away from the substrate 74 adjacent to the prosthetic shaft. , Pressed against the prosthetic shaft. In the illustrated embodiment, the sealing lip 16 is not formed to project vertically from the outer side 76 of the substrate 74, but is formed or arranged at an angle. The inside of the sealing lip 16 facing the substrate 74 forms an acute angle between them. Basically, the opposite orientation can be set or the sealing lip 16 can be projected vertically. When the prosthesis liner 2 is introduced into the prosthesis shaft, the sealing lip 16 is normally folded back so that the distal side of the sealing lip 16 is oriented adjacent to the inside of the prosthesis shaft. In the case of negative pressure to atmospheric pressure in the volumetric space between the prosthetic shaft and the region distal to the encapsulation lip 16 sealed by the encapsulation lip 16, the encapsulation lip 16 is the prosthetic shaft. Since it is pressed against the inner wall of the space, a self-reinforcing sealing effect is produced.

From FIG. 8, the proximal edge 70 of the prosthesis liner 2 is formed so as to be arranged linearly or in one plane, the plane being substantially perpendicular to the longitudinal extension of the prosthesis liner 2. You can read that you are running. The sealing lip 16 deviates from its longitudinal extension and is not in a common plane, especially in a plane parallel to or tilted with respect to the proximal edge 70 of the prosthesis liner 2. It runs along the spatial curve running along its proximal edge corresponding to the curve of the height contour. In the illustrated embodiment of FIG. 8, the prosthetic device liner 2 for the lower leg is shown. The tibial head is shown by the dashed line. The sealing lip 16 runs just above the tibial head in the anterior region and extends inward and laterally towards the proximal end 70. The sealing lip 16 may also run to descend again distally at the posterior portion of the prosthetic device liner. Such curves correspond to the curves of the proximal edge of the lower leg shaft running deeper than medial and lateral in the anterior tibial and patellar regions, i.e., further distally. In order to increase lateral stability and improve the pressing of the lower leg shaft against the stump, the prosthetic shaft region may be positioned to run proximally again medially and laterally of the knee joint.

In FIG. 9, the artificial orthotic device liner 2 according to FIG. 8 in the attached state is shown in a schematic view. The prosthesis liner 2 is pressed against a stump (not shown) and is introduced into the prosthesis shaft 80. The prosthesis shaft 80 has a proximal edge 82 that is not in a flat plane and draws a space curve. The prosthetic shaft 80 has areas that are raised high on the medial and lateral sides, which extend proximally to the area located anteriorly and within the area of the patella. A cutout may be seen on the anterior surface that allows the movement of the patella. In the posterior region of the patellar region, a corresponding cutout or corresponding descent is formed to allow flexion of the foot, and the prosthetic shaft is sandwiched between the posterior thigh and calf region in its posterior region. There is no.

The prosthesis liner 2 is fully introduced into the containment space 84 of the prosthesis shaft 80, i.e. the distal end 72 of the prosthesis liner 2 is within the region of the distal end 88 of the prosthesis shaft 80. Is located above its distal end by, or lightly away from its distal end, eg, via a buffer. The sealing lip 16 is adjacent to the inner wall of the artificial device shaft 80 and provides a volumetric space 86 between the inner wall of the artificial device shaft 80 and the outer wall 76 of the artificial device liner 2 distal to the sealing lip 16. It is hermetically sealed. The volumetric space 86 is evacuated, for example, by pumping motion during walking by a discharge valve or by a motor driven pump, that is, to a pressure level below atmospheric pressure.

From FIG. 9, the sealing lip curve corresponds to or follows the curve of the proximal edge 82 of the prosthesis shaft 80 and is simply distally offset outside or located on the substrate 74. Can be read. Ideally, the sealing lip 16 runs a minimum distance to the proximal edge 82 of the prosthetic shaft 80. In particular, the elevation curve or elevation contour, i.e., the curve of the sealing lip 16 around the periphery of the substrate 74 in the proximal and distal directions, corresponds to the elevation curve of the proximal edge 82 of the prosthetic shaft. There may be a small amount of deviation, in particular the sealing lip curve may be fixed within the corresponding region approximately parallel to the curve of the height contour of the proximal edge 82 of the prosthesis shaft 80. The proximal and distal boundaries of the region are then formed to correspond to the height contour curve of the proximal edge 82.

Further, the contour in the peripheral direction, that is, the contour of the inner circumference of the artificial device shaft 80 in the pressing region of the sealing lip 16 can also be obtained. The contour of the outer circumference of the sealing lip 16 may be formed with an addition corresponding to the curve of the peripheral contour within the region where the outer sealing lip edge is pressed against the inside of the prosthesis shaft 80, thus sealing. The stop lip 16 may be adjacent to the inside of the prosthesis shaft 80 with a light pressurization based on the restoring force at the time of deformation after the prosthesis liner 2 is introduced into the prosthesis shaft 80.

Instead of the morphology of the prosthesis shaft 80 as a lower leg shaft with ridges on the medial and lateral sides, for example, the morphology as a thigh shaft comprises a unilateral ridge that extends approximately to the axis of rotation of the hip joint. A corresponding distally offset cutout is formed on the medial side of the thigh so that the thigh liner adjusts the corresponding sealing lip curve.

In order to produce such a liner 2, first, the height contour of the artificial device shaft 80, which is generally individually produced, is detected. Therefore, the height of the prosthesis shaft 80, i.e., the distance from the proximal edge 82 to the inner distal end 88 of the prosthesis shaft 80 along the perimeter of the stump is also detected. Shapes and dimensions can preferably be detected optically, for example by image acquisition and image evaluation. Alternative detection data such as scanning or tracking running with measurement acquisition may be performed as well.

Based on the detected curve of the height contour of the proximal edge 82, where the sealing lip 16 will be adjacent inside the prosthesis shaft, thus the sealing lip is outside 76 of the substrate 74 of the prosthesis liner 2. The place to be placed is fixed. The detected data is used to create a 3D data model. Based on the data model of the prosthesis shaft 80, the liner 2 is directed towards, for example, the curve of the standard substrate 74 and the proximal edge 82 of the prosthesis shaft 80 with the individual encapsulation lip curves of the encapsulation lip 16. Is constructed using. The shape of the prosthetic device liner 2 with a matched sealing lip curve is similarly calculated as a 3D data model. Fabrication data is generated based on the 3D data model. Based on the fabrication data, using at least one additional fabrication method, the prosthesis liner 2 with a sealing lip curve is made to correspond to the curve of the proximal edge 82 of the prosthesis shaft.

FIG. 10 shows possible progress in the method of making the prosthetic device liner 2. The cut stump 66, in the present specification, from the lower leg stump, the outer contour of the cut stump 66 is acquired, eg, scanned, via an optical detection device 90. A three-dimensional model is created from the cutting stump 66 and organized in a computer (not shown). Based on the three-dimensional model, a data set 92 that at least substantially represents the shape of the later prosthetic device liner 2 is calculated. The data set 92 also fixes the outer contour of the prosthesis liner 2 along with the sealing lip curve, in particular the distal end region 72 of the prosthesis liner 2 and the material thickness. Data sets 92 can be used to determine reinforcement, material weakening, and the use of different materials used or incorporated into the fabrication process. Based on the data set 92, an actual prosthetic device liner 2 can be made. The curve of the proximal edge 70 or the proximal edge 70 of the actual prosthesis liner 2 in space has not yet been drawn as fixed within the data set 92 in this example. The remaining contour of the prosthetic device liner 2 is shown by the dashed line. A data set for the prosthesis shaft 80 can be created based on the data set 92 or the basic data of the scan, which data set forms the basis for making the prosthesis shaft, for example in an additional fabrication method. .. The sealing lip curve in that space is defined as a contour line and can be used as a reference to the contour curve of the proximal edge 82 of the prosthesis shaft 80. That is, first, the sealing lip curve of the sealing lip 16 on the outside of the prosthetic device liner 2 that should still be made can be determined. Next, the artificial device shaft 80 is formed. Conversely, it is possible to align the sealing lip curve with the already fixed contour of the proximal edge 82 of the virtual or existing prosthetic shaft 80.

Based on the data set 92, the prosthetic device liner 2 is made using an additional fabrication method. In the illustrated embodiment, fabrication is performed by a so-called high speed liquid printing method, in which the supporting material 94 is placed in a tank or storage container. The material of the artificial device liner 2 is inserted into the support material 94 via the outflow nozzle 42 that can move in the three-dimensional direction in the space, and the artificial device liner 2 is additionally manufactured. The dashed line indicates the contour of the proximal end of the prosthetic device liner 2, and the contour of the proximal end is linear in the illustrated embodiment. The proximal end contour or proximal edge 70 of the prosthesis liner 2 may run corresponding to the curve of the sealing lip 16 or to the proximal edge 82 of the prosthesis shaft 80.

2 Artificial Orthotic Device Liner 4 Opening 6 Liner Cap 8 Cushion 10 Electrode 12 Fabrication Material 14 Source 16 Sealing Lip 18 Position Box 20 Nod 22 Connecting Element 24 Cable 26 Conductive Line 28 Label Line 30 Design Element 32 Wear Marker 34 Central Region 36 Edge Area 38 Vacuum Path 40 Fiber Layer 42 Outflow Nozzle 44 Partitioned Volume Space 46 Volume Storage Layer 48 Inlet 50 Outlet 52 Lead Valve 54 Path 56 Arrow 58 Insole 60 Artificial Orthotic Device Shaft 62 Prosthesis Gloves 64 Wind Scale 66 Cutting Stump 68 Scanner 70 Proximal edge 72 Distal end area 74 Base 76 Outer 78 Inner 80 Artificial device shaft 82 Proximal edge 84 Containment space 86 Volumetric space 88 Distal end 90 Optical detection device 92 Data set 94 Support material

Claims (15)

A method of making an artificial prosthesis, particularly an orthotic device liner (2), wherein the artificial prosthesis is made from at least one fabrication material (12) using at least a partially additional fabrication method. A method characterized in that the material is inserted into the supporting material in a fluid state and then cured. The fabrication material (12) is characterized in that it is supported by the supporting material during curing and / or held in its position in the work space, preferably a self-curing material or a material that can be cured by increasing temperature. The method according to claim 1. The production material (12) is composed of at least two components, and preferably the mixing ratio of the at least two components can be adjusted while performing the additional production method. The method according to 2. The method according to claim 3, wherein the prepared material (12) has a shore hardness whose value depends on the mixing ratio after the curing. The method according to claim 1, wherein at least two different production materials (12) are preferably used simultaneously in the additional production method. One of claims 1-5, characterized in that, during the additional fabrication method, the at least one fabrication material (12) is coupled to a separately crafted component of the artificial corrector. The method described in. Since the wall thickness of the artificial corrector can be changed in a continuous or discrete step in the additional fabrication method, at least one bulge, depth, thickness, taper and / or retaining is produced. The method according to claim 1 to 6. The method according to claim 1, wherein an artificial compensator having at least one hollow space is generated by using the additional manufacturing method. The at least one hollow space is at least partially, preferably completely filled with at least one filling material, and preferably at least two hollow spaces are filled with different filling materials during the additional fabrication method. The method according to claim 8, wherein the method is characterized by the above. From the at least one fabrication material (12) using the additional fabrication method, at least one pneumatic element and / or at least one hydraulic element, preferably at least one volumetric reservoir (46), at least one seal. Claim (16), wherein a stop lip (16), at least one valve and / or at least one pump are made, and the element is preferably made integrally with another part of the artificial corrector. The method according to item 1 of 1. The measurement data is detected from the patient and made available for electrical and / or electronic control, and the control is arranged to control the additional fabrication method at least also based on the measurement data. The method according to claim 1, wherein the method is characterized by. The artificial prosthesis is an artificial device liner (2) for use within the artificial device shaft (80), wherein the artificial device shaft (80) has a distal end (88) and a proximal edge (82). This method has the following steps,
a) On the outside (76) of the prosthesis liner (2), corresponding to the curve of the height contour of the prosthesis shaft (80) or based on the available well-known anatomical data of the cut stump. Fixing the sealing lip curve and
b) Using the at least one additional fabrication method, the sealing lip (16) is placed on the outside (76) of the prosthetic device liner (2) along the fixed sealing lip curve. The method according to claim 1, wherein the method is characterized by having. The sealing lip (16) is disposed distally to the proximal edge (82) of the prosthesis shaft (80), particularly equidistantly on the prosthesis liner (2). The method according to claim 12, wherein the method is characterized by the above. The height contour of the prosthetic device shaft (80) is optically detected, a digital three-dimensional model is created, and the sealing lip curve is fixed according to the detected height contour. The method according to claim 12 or 13. An artificial compensator made or can be made according to the method according to any one of claims 1 to 14.

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